Evaluation of the Signals électrophysiologiques Measured by Intelligent Textiles
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- BioSerenity
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Sensor quality validation
研究概览
简要总结
BioSerenity suggests developing innovative solutions, from intelligent clothes which can be used in a hospital environment or at home. These textiles allow, in particular, to measure the biophysiological signals while letting to the participant the freedom pursue its daily activities.
BioSerenity has already developed two wearable wireless and portable medical devices: cardioskin with textile ECG electrods , and the Neuronaute with textile EEG, EMG electrods.
The aim of the study is to test these sensors to optimize their signal to integrate them in future Bioserenity devices like a somnonaute to help diagnosis of sleep disorders, like uronaute to help diagnosis of urination disorders, like toconaute to help monitoring of pregnancy. Others CE-marked sensors developed by others manufacturers will be tested to choose those that will be integrated in the Bioserenity devices.
详细描述
The various alone sensors tested in the clinical trial (sensors of Bioserenity and the other manufacturers), will supply information which will allow to develop future devices. Some of these sensors will then be selected to integrate them.
The tests will be made according to the therapeutic area of the concerned device(plan). There are 5 therapeutic areas:
Cardiovascular (Cardioskin device), neurology ( Neuronaute device), urology ( Uronaute device), obstetrics ( Toconaute device), somnologie (Somnonaute device).
One subject would likely test either one sensor of a device or multiple sensors, either an entire device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •women or men >18 years
- •affiliation to a social security system
排除标准
- •Wounds or wounds on the body and the scalp;
- •Refusal of consent, minor
- •Not membership to the Social Security
- •Participant not capable of following the procedure of use (according to the judgment of the investigator);
- •Brain surgery that took place less than a week ago
- •Allergy known about the money, the polyamide, the silicone, the synthetic materials;
- •Sensory Disorders(Confusions) returning the insensible subject to the pain;
- •Motor or mental disorders preventing the subject from expressing his pain;
- •Behavioral problems that make the subject excessively agitated or aggressive;
- •People with cardio-respiratory problems likely to be aggravated by the slight compression of the thorax;
- •Subject equipped with an electrical stimulation device;
- •Unsuitable anthropometric Parameters (for the women, the sizes superior to 24 will be excluded and for the men(people) those superior to 34);
- •Pregnancy clinically detectable or known for the subject;
- •Current(in class) Participation in a clinical trial or participation in a previous clinical trial understanding(including) a period of not past(over) deficiency at the time of this clinical trial.
- •Predisposition in the headaches of tension (the compression exercised by the hat(cap) can activate(start) in certain cases a headache);
- •Use of the device(plan) within the framework of a resuscitation or of intensive care;
- •Participating carrier of a defibrillator, a stimulating of the vagus nerve, or quite different surgical high-frequency device.
结局指标
主要结局
Sensor quality validation
时间窗: 24 months
Signal is considered as of "good quality" " not good quality" regarding criteria of signal patterns : eg amplitude of signal, regularity..
次要结局
未报告次要终点